| Subject: |
State drug regulators tap USFDA to polish skills on good manufacturing |
|
NEW DELHI: Indian state drug regulators have started tapping global safety firms which train investigators of the US Food and Drug Administration to brush up skills of their own inspectors.
Gujarat state food and drug control administration (FDCA) on Monday enlisted the Indian arm of Underwriters Labs (UL), a US-headquartered safety consultancy, to coach 45 of its inspectors on good manufacturing practices, its commissioner Hemant Koshia confirmed to ET over phone.
UL, with presence in 46 countries, claims to have trained over 36,000 USFDA investigators over the past two-three decades 'in an exclusive partnership'.
The safety firm is also talking to other states with a high concentration of pharma units, including Maharashtra, Uttarakhand and Andhra Pradesh for similar tie-ups. The move comes in the backdrop of a rising number of India-based drugmaking facilities coming under the US regulator's gaze since 2013.
Over 30 India-based drug-making units have been banned from shipping to the US in the past two years, including those belonging to leading pharma companies such as Sun Pharma, Ranbaxy Labs (in the process of getting acquired by rival Sun), Wockhardt, as the US drug regulator stepped up its scrutiny here.
"Gujarat is home to almost a third of drug production in the country and many of these pharma companies manufacture for the country as well as for exports to developed markets from the same facilities. We would want our inspectors to train with the best, and UL's training is aligned with the vision of the US FDA, the strongest drug and food regulating agency in the world," said Koshia.
He added that besides training on rapidly evolving current good manufacturing practices, Gujarat FDCA has also asked the safety firm to customise its training for Indian needs and environment.
"These are just the first few steps. We are in talks with other states to replicate the model," said Suresh Sugavanam, managing director, UL, South Asia. Besides GMPs, UL would also focus on principles of good documentation while training inspectors.
Many Indian drug manufacturers — small and big have been especially found wanting by the USFDA in this department of maintaining proper recordkeeping and an audit trail.
A total of seven Indian facilities were under import alert (ban on drugs from a plant) imposed by the US regulator in 2011, nine in 2012, and 32 in March 2014, reckons an India Ratings & Research estimate of May 2014. In 2013 alone, the USFDA banned 21 Indian manufacturing facilities from shipping, the highestever for India in any single year.
Source : economictimes.indiatimes.com
|